Executive Director, CMC and Technical Operations - Codera, LLC : Job Details

About Codera

Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.

Position Summary

The Executive Director, CMC and Technical Operations will oversee the development and execution of chemistry, manufacturing and controls (CMC) activities to advance domestic and international drug development programs from early development through commercialization. Drug development programs may include drugs and biologics. Product candidates may include solid oral dosages, injectables and drug-device combination products (e.g., dry powder inhalers).

Essential Duties and Responsibilities

• Oversee development and execution of CMC activities
• Manage contract manufacturing organizations (CMOs) responsible for drug substance and drug product manufacturing, analytical testing, labeling and packaging
• Ensure that drug substance and drug product control strategies and specifications are appropriate to meet relevant regulations
• Design, conduct and report results for drug substance and drug product characterization
• Develop, validate and continuously improve analytical methods
• Collaborate with regulatory to assure accurate and complete CMC regulatory filings
• Collaborate with quality assurance on vendor qualification and maintenance processes
• Develop and implement appropriate metrics to measure manufacturing goals and objectives, including production cost and quality benchmarks

Qualifications

• Bachelor's or higher Degree in Pharmaceutical Sciences, Biology, Biochemistry, Chemical/Biochemical Engineering, or related field required
• Advanced degree preferred
• Minimum 5 years of CMC and technical operations experience within the biotechnology or pharmaceutical industry
• Experience with drug-device combination products
• Deep understanding of drug development strategies, operations, cGMP regulations, formulations and differentiated drug delivery products
• Outstanding written and verbal communication skills, including the ability to use clear language to explain complex matters
• Possess a willingness and ability to work hands-on in a detail-driven, fast-paced, entrepreneurial environment
• Ability to travel up to 25%

Codera, LLC is an equal opportunity employer. Codera, LLC participates in E-verify.